ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

Last updated: February 21, 2025
Sponsor: Hospital Universitari de Bellvitge
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Chemotherapy

Treatment

Lymphadenectomy

Axillary Radiotherapy

Clinical Study ID

NCT04889924
PR148/21
  • Ages > 18
  • All Genders

Study Summary

In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy.

The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • T1-T4 N0/ T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment

  • Post-CT SLN with ≤2 macrometastasis/micrometastasis or ITCs

  • Post-CT axillary response by ultrasound or MRI

  • Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrinetreatment.

Exclusion

Exclusion Criteria:

  • cN2

  • ypN0

  • History of breast surgery for ipsilateral cancer in the last 10 years

  • History of other cancer in the last 5 years, except squamous carcinoma of the skin.

Study Design

Total Participants: 1660
Treatment Group(s): 2
Primary Treatment: Lymphadenectomy
Phase:
Study Start date:
June 01, 2021
Estimated Completion Date:
December 31, 2026

Study Description

A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 1660 patients, over 5 years. Patients will be stratified and analyzed independently according to the neoadjuvant treatment regimen, whether chemotherapy (CT) +/- hormonal therapy (HT).

A pilot phase of the study was carried out with the first 200 patients. An interim analysis will also be performed with the first 820 patients recruited.

Connect with a study center

  • GenesisCare Campbelltown

    Sydney, New South Wales 2560
    Australia

    Active - Recruiting

  • GenesisCare Frenchs Forest

    Sydney, New South Wales 2086
    Australia

    Active - Recruiting

  • GenesisCare Hurstville

    Sydney, New South Wales 2220
    Australia

    Active - Recruiting

  • GenesisCare Mater

    Sydney, New South Wales 2060
    Australia

    Active - Recruiting

  • GenesisCare North Shore

    Sydney, New South Wales 2065
    Australia

    Active - Recruiting

  • GenesisCare Norwest

    Sydney, New South Wales 2153
    Australia

    Active - Recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Instituto Catalán de Oncología de Badalona

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Comarcal Sant Jaume de Calella

    Calella, Barcelona 08370
    Spain

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    Hospitalet de Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Consorci Sanitari Integral

    L'Hospitalet De Llobregat, Barcelona 08906
    Spain

    Active - Recruiting

  • Instituto Catalán de Oncología- Hospital Duran i Reynals

    L'Hospitalet De Llobregat, Barcelona 08908
    Spain

    Active - Recruiting

  • Fundación Althaia Manresa

    Manresa, Barcelona 08243
    Spain

    Active - Recruiting

  • Hospital de Mataró

    Mataró, Barcelona 08304
    Spain

    Active - Recruiting

  • Hospital Universitario General de Cataluña

    Sant Cugat Del Vallès, Barcelona 08195
    Spain

    Site Not Available

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona 08227
    Spain

    Active - Recruiting

  • Hospital Universitario Mútua Terrassa

    Terrassa, Barcelona 08221
    Spain

    Active - Recruiting

  • Hospital de Viladecans

    Viladecans, Barcelona 08840
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo, Bizkaia 48903
    Spain

    Active - Recruiting

  • Hospital Universitario Galdakao-Usansolo

    Galdakao, Bizkaia 48960
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz, Cádiz 11009
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia, Gipuzkoa 20014
    Spain

    Active - Recruiting

  • Hospital Universitario Príncipe de Asturias

    Alcalá De Henares, Madrid 28805
    Spain

    Active - Recruiting

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid 28914
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta De Hierro

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Cristina

    Parla, Madrid 28981
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Hospital Ribera Povisa

    Vigo, Pontevedra 36211
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra 36213
    Spain

    Active - Recruiting

  • Hospital Universitario de Canarias

    La Laguna, Santa Cruz De Tenerife 38320
    Spain

    Active - Recruiting

  • Hospital Universitario Sant Joan de Reus

    Reus, Tarragona 43204
    Spain

    Active - Recruiting

  • Hospital Universitario de Álava / Txagorritxu

    Vitoria, Álava 01009
    Spain

    Active - Recruiting

  • Hospital Universitario de A Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital Clínico y Provincial de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital de la Santa Cruz y San Pablo

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006
    Spain

    Active - Recruiting

  • Hospital Universitario de Gerona Doctor Josep Trueta

    Girona, 17007
    Spain

    Active - Recruiting

  • Institut Catalán de Oncología de Girona

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía

    Madrid, 28703
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Málaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hospital Montecelo

    Pontevedra, 36071
    Spain

    Active - Recruiting

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz De Tenerife, 38010
    Spain

    Active - Recruiting

  • Hospital General de Segovia

    Segovia, 47002
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital Universitario de Tarragona Juan XXIII

    Tarragona, 43005
    Spain

    Active - Recruiting

  • Instituto Valenciano de Oncología

    Valencia, 46009
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Hospital Recoletas Campo Grande de Valladolid

    Valladolid, 47007
    Spain

    Active - Recruiting

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